Prevention of early ventilator-associated pneumonia with antibiotic therapy in patients treated with mild therapeutic hypothermia after cardiac arrest. Randomized, multicenter double-blind placebo-controlled trial. - ANTHARTIC

CHU de LIMOGES0 个研究点目标入组 194 人开始时间: 2015年6月22日最近更新: 2022年4月4日

适应症

试验速览

暂无简介。

•-Patients older than 18 years-old, mechanically ventilated after an out-of-hospital resuscitated cardiac arrest secondary to shockable rhythm
•-Hospitalized in an ICU
•-Mild therapeutic hypothermia procedure scheduled (24 to 36 hours) before randomization
•-Delay from ROSC to randomisation < 6 hours
•-Consent from family members or emergency consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 92
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•-Pregnant women
•-Out-of-hospital cardiac arrest secondary to non shockable rhythm (mild therapeutic hypothermia not yet evidence based”)
•-In-hospital cardiac arrest
•-Need for cardiac support by cardiopulmonary bypass
•-Ongoing antibiotic therapy or during the week before
•-Ongoing or concomitant pneumonia
•-Known chronic colonization with MRB
•-Known severe allergy to beta-lactame antibiotics (Quincke edema, shock) and amoxicillin-clavulanic acid use contraindications
•-Previous lung disease making radiological interpretation difficult for VAP diagnosis
•-Predictable decision of early care limitation or withdrawal (< 7 days)
•-Moribund patient
•-Participation in any other clinical study that involves the administration of medication at the time of randomization or during the 30 days prior to study start or which can influence primary outcome
•- Patient under guardianship or curatorship

发起方

CHU de LIMOGES